John Wilbanks: Improving informed consent through design to advance science

Whenever you go to a doctor’s office in the United States you are asked to fill in a form and give your consent to the medical treatment that you need. Informed consent is the “process by which the treating health care provider discloses appropriate information to a competent patient so that the patient may make a voluntary choice to accept or refuse treatment.”

A similar process of informed consent is used by researchers when enrolling patients into clinical trials and studies. Anyone who has been asked to fill in an informed consent form, knows that the process is cumbersome and far from user-friendly. More importantly the way we collect informed consent may potentially hamper research and innovation in how trials are conducted. John Wilbanks, Chief Commons Officer at Sage Bionetworks seeks to transform and innovate in medical research by accelerating data sharing between clinical studies.

He explained at the latest GovLab Ideas Lunch that for his mission to succeed, he was forced to focus on how to re-design the existing informed consent process and interface.

At the talk, Wilbanks presented an open source toolkit for obtaining informed consent in clinical studies. By simplifying and increasing the comprehension of the consent process, more patients may be willing to enroll in clinical studies radically increasing the amount of data collected.

Sage Bionetworks has put their innovation to the test by designing an application to conduct a Parkinson’s disease study that aims to attract 18,000 participants, 10 times larger than the biggest study on this condition. The simplified consent form would allow them to work with more people and, using data collected through mobile phones, analyze how Parkinson’s progresses over time. The phone interface allows researchers to measure gait, motor ability and vocal capacity – the same tests that a doctor would apply when examining a patient in person. Patients in the study are granted access to their data and that (anonymized) data is then opened for other scientists to analyze after the study is concluded.

The interface was created through an interaction design process. Sage Bionetworks conducted 38 interviews and worked with sociologists to use the most important sentences of the consent form, that would enable a higher understanding. To encourage people to read and not just swipe “continue,” they put some friction in the process, like, for example, asking participants to shake the phone to recognize that they will use the phone’s sensors. The consent process consists of 11 screens, informing the patient of the potential benefits, risks, and what they will do with the data. At the end, participants must answer 5 questions to test their comprehension.

The outcome of this redesign of the consent process is that the patient is fully informed and aware of the benefits and risks of participating in the study and what will be done with the data that is generated.

The toolkit

SageBionetworks is sharing their innovation with all those interested through the participant-centered consent toolkit. It is accessible for free and under creative commons. Available in mobile and print formats, the toolkit includes icons and animations that convey core concepts of clinical studies, such as risks or the need to take surveys. They also released the documents they presented to the Independent Review Board, templates, FAQ, storyboard layouts for the app, software workflows, and standard web assets, like the landing pages for the app.

Currently SageBionetworks is working with four partner institutions and five implementations are underway.

Key Takeaways

Wilbanks talk and his work on opening and improving informed consent uncovered four key takeaways:

Improving the informed consent process for clinical studies can generate important benefits like sharing anonymized data for scientists and researchers to reuse for the benefit of public health.

By introducing design patterns in the consent process that currently has similar parts, it is possible to generate some standardizations in order to pave the way for future interoperability of clinical study data.

Physicians and scientists are likely to embrace the changes in the consent process, because the content will be maintained but design patterns will improve. This will be aided by the fact that the professionals are not currently happy with how the consent process works.

There is great potential in the scaling of this type of technology, as it would facilitate the design of clinical trials where people donate their data to science. The app could allow health practitioners to communicate with patients bidirectionally. Due to its possibilities, the tool has to be ethically, technically and legally sound.